Why Does Purity Matter?

Wondering if investing in a higher purity excipient is really going to pay off? Check out our video web series where we speak to 3 subject matter experts on the benefits of using high purity ingredients and their effects on various aspects of the pharmaceutical value chain. Our series has us speaking to experts who have us thinking about how impurities can affect R&D, manufacturing, and customer savings.


Croda Health Care
North America
E: marketing-usa@croda.com

Europe, Middle East, Africa
E: hc-europe@croda.com

Latin America
E: healthcare.latam@croda.com

Asia
E: hc-asia@croda.com

W: www.crodahealthcare.com

 

Pharmaceutical formulators continue to strive to create market leading products with maximum efficacy, quality, and performance. However, the inability to achieve a high level of API solubility and stability are common day-to-day challenges which limit product success. With the help from Croda’s superior quality and high purity line of specialty excipients, formulators are able to surpass these barriers, making Croda the supplier of choice in the global pharmaceutical market. With products being manufactured at multiple sites throughout the world, we are able to provide a consistent, local supply of a vast range of high purity surfactants, lipids, and other chemical specialties.

Croda also provides a large selection of products for topical dosage forms, as well as multi-compendial solvents and surfactants suitable for parenteral, oral, ophthalmic, nasal, vaginal, and suppository applications to help formulators maximize the value of their final drug product.

Croda has developed a proprietary line of products called Super RefinedTM excipients to help create products of superior quality and purity. These products have undergone intense purification to remove problematic impurities without compromising the fundamental structure of the excipient itself. Super Refined products can help resolve a number of drug development challenges, including formulation instability, inadequate shelf-life, and API degradation. In addition, Croda has been actively investing in GMP API technologies and R&D to ensure the continual delivery of exceptional ingredients, including expertise in drug delivery, vaccine adjuvants, and novel phospholipid ingredients. We consider future health and wellness needs when creating new specialty products.

HIGH-PERFORMANCE PRODUCTS

Croda offers a complete (and constantly growing) range of multicompendial and high purity excipients for various dosage routes and formulations. The company’s products include:

  • Super RefinedTM Range of Excipients

-CCMG 400: high purity caprylocaproyl macrogolglycerides
-DEGEE: high purity diethylene glycol monoethyl ether
-Dimethyl isosorbide: high purity solvent for hydrophilic and lipophilic APls, enhancing skin penetration
-Oils: sesame, soybean, peanut, corn, olive, safflower, castor, and cottonseed
-Oleic acid: high-purity, multi-compendial excipient
-P35 Castor Oil: high-purity polyoxyl 35 castor oil
-PEGs: high-purity, multi-compendial polyethylene glycols
-Polysorbates: multi-compendial, high purity Polysorbate 20, 60, and 80
-Propylene glycol: high purity, multi-compendial solvent

  • CrodacolTM Range: fatty alcohols
  • CrodamolTM Range: a range of ester solvents and vehicles
  • CrodestaTM Range: sucrose esters for mild emulsification and sustainable release in tablet applications
  • MedilanTM: medical grade lanolin designed to surpass USP requirements for lanolin, modified
  • PolawaxTM: a complete compendial and self-emulsifying wax
  • SynperonicTM Range: a range of monograph compliant poloxamers